F. De Caro (Pavia, IT)Istituto di Cura Città di Pavia Ortopedia
Presenter Of 2 Presentations
24.1.3 - Effect of the Meniscus’s Condition On Outcome of Aragonite-Based Implant For Repair Of Knee Joint Surface Lesions: Results From RCT
Meniscal tissue loss has been hypothesized as a risk factor in cartilage healing following regenerative procedures. The objective of this study was to investigate the effect of the meniscus’s condition on the clinical outcome of an aragonite-based scaffold implantation in knee joint surface lesions.
Methods and Materials
Subjects were enrolled into a large multicenter RCT. They were randomized to receive either an aragonite-based scaffold (Agili-C™, CartiHeal Ltd., Israel) (n=167) or arthroscopic debridement/microfractures (control group, n=84). The two treatment groups were further stratified based on the condition of the meniscus, differentiating between subjects who had previous partial meniscectomy, those who underwent concomitant partial meniscectomy during the study treatment, and those who presented an intact meniscus. The magnitude of change in the KOOS score was evaluated at 6, 12, 18 and 24 months to assess whether previous meniscectomy or concurrent meniscectomy correlated with clinical outcome. Furthermore, results were compared between the scaffold and the control group.
In the scaffold group, 94 subjects had an intact meniscus, 23 had previous partial meniscectomy, and 47 required concomitant meniscectomy during study treatment. No significant difference was noted between the 3 sub-groups regarding KOOS score change from baseline to 24 months: previous meniscectomy patients showed an increase of 39.5 points, concomitant meniscectomy 42.9 points, and intact meniscus 43.2 points (p=n.s.). A significant improvement in the scaffold group (all 3 subgroups) was found compared to the control group, where previous meniscectomy patients (n=18) increased 15.3 points, concomitant meniscectomy (n=18) 29.3 points, and intact meniscus (n=44) 30.9 points (p<0.0001), with a larger treatment effect observed in subjects with previous meniscectomy, mostly due to the lower degree of improvement in the control group.
The aragonite-based scaffold provided a comparable clinical performance, not dependent on the meniscus’s condition (previous, concurrent or no meniscectomy), with significantly better outcomes than control group.